The Effect of Gluten in Patients With Irritable Bowel Syndrome and Healthy Volunteers

Study Purpose

Patients with Irritable Bowel Syndrome (IBS) often link their symptoms to foods. Interest in
dietary management recently increased, including the use of a gluten-free diet.
To investigate relation of gluten-free diet (GFD) and IBS, a randomized, double-blind,
placebo-controlled cross-over trial will be carried out in adults (>18) and patients with IBS
according to Rome IV criteria. The aim is to assess gluten-free versus gluten-containing diet
in IBS patients and Healthy Volunteers.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes

Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.

An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.

Searching Both is inclusive of interventional and observational studies.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

The disease, disorder, syndrome, illness, or injury that is being studied.

Irritable Bowel Syndrome

Additional Details

The study is a randomized, double-blind, placebo-controlled, cross-over trial.
The aim is to assess the effects of gluten-free diet (GFD) compared to gluten-containing diet
(GCD) in IBS patients and Healthy Volunteers on gastrointestinal symptoms, visceral
sensitivity, bacterial fermentation, psychological factors and quality of life. The primary
hypothesis is that GFD decreases gastrointestinal symptoms compared to GCD and that this
change is accompanied with reduced visceral sensitivity and change in bacterial fermentation.
The secondary hypothesis is that GFD positively influences psychological factors and quality
of life.
IBS patients (Rome IV) and Healthy Volunteers are challenged with gluten in this randomized,
double-blind, placebo-controlled, cross-over study. They start with GFD or GCD and cross over
to the other intervention (both for 14 days). In between there is a wash-out period of at
least 14 days. The subjects will get gluten-free meals (lunch and dinner) and have to
sprinkle powder over the meals, concealed in sachets with either gluten (vital gluten) or
placebo (rice starch). The subjects will follow a strict GFD during the GFD and GCD periods.
The subjects will eat and drink as before the study during the washout period.
Primary outcomes are change in gastrointestinal symptoms, assessed by questionnaires,
including IBS Severity Scoring System (IBS-SSS) and Gastrointestinal Symtom Rating Scale-IBS
(GSRS-IBS). A 50-point reduction in IBS-SSS indicates clinical response. Bacterial
fermentation (exhaled hydrogen and methane) and visceral sensitivity will be measured using
the Lactulose-Nutrient Challenge Test. Secondary outcomes are change in psychological factors
and quality of life assessed by questionnaires, including CSI, HADS, HSPS, IBSQOL, PHQ-15 and
VSI.

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